Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy

NCT03830788 | Recruiting

• 1 other identifier: 2016-2-10-003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 20

Brief Summary

The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment. Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers. In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.

Conditions

Prostate Cancer

Keywords

SBRT; brachytherapy; localized low-risk and intermediate risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy

  The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.

  3 years after treatment.

Secondary Outcomes (2)

• Cost-utility analysis of SBRT compared to "standard" iodine-125 brachytherapy

  5 years after treatment

• Cost-utility analysis of avoided erectile dysfunction cost

  3 and 5 years after treatment

Study Arms (2)

Brachytherapy

ACTIVE COMPARATOR

radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate

Radiation: Radiation by brachytherapy

stereotactic body radiotherapy (SBRT)

EXPERIMENTAL

radiation by SBRT: SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate. The prostate can be tracked/localized/treated thanks to the Cyberknife or a conventional linac equipped with an ExacTrac or a Calypso4D system.

Radiation: Radiation by SBRT

Interventions

Radiation by brachytherapy RADIATION

Brachytherapy by Iodine 125 delivering 144 Gy to the prostate

Brachytherapy

Radiation by SBRT RADIATION

SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate.

stereotactic body radiotherapy (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven prostate adenocarcinoma,
• Low risk prostate cancer according to d'Amico (T1-T2a and PSA \<10 ng/ml, and Gleason score 6) or intermediate risk prostate cancer according d'Amico but excluding tumor with Gleason score 7 (4 + 3),
• Indication of a curative treatment by brachytherapy validated in multidisciplinary consultation meeting,

You may not qualify if:

• Androgen deprivation therapy,
• Contraindication for prostate Iodine 125 brachytherapy (Prostate volume \> 50 cc, impossibility if general anesthesia).
• Contraindication for Resonance Magnetic Imagery (RMI) (claustrophobia, pacemaker)
• Participation to another research which could have an impact on the study treatment and the outcomes

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (20)

Clinique Claude Bernard

Albi, France

NOT YET RECRUITING

ICO Paul Papin

Angers, 49055, France

RECRUITING

Institut Bergonié

Bordeaux, France

NOT YET RECRUITING

Polyclinique Bordeaux-Aquitaine

Bordeaux, France

RECRUITING

CLCC Georges-François Leclerc

Dijon, France

RECRUITING

Centre Amethys - Charlebourg - La Défense

La Garenne-Colombes, 92250, France

RECRUITING

Centre de Cobalthérapie Hartman

Levallois-Perret, France

NOT YET RECRUITING

CH Lyon Sud

Lyon, France

TERMINATED

Institut régional du Cancer de Montpellier

Montpellier, France

NOT YET RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Hôpital Lyon Sud

Pierre-Bénite, France

TERMINATED

Institut Jean Godinot

Reims, France

NOT YET RECRUITING

Centre Eugene Marquis

Rennes, 35042, France

RECRUITING

Centre d'oncologie et de radiothérapie Saint Jean

Saint-Doulchard, France

RECRUITING

Institut de Cancérologie de l'Ouest - Site Gauducheau

Saint-Herblain, France

RECRUITING

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

NOT YET RECRUITING

Institut Claudius Régaud

Toulouse, France

NOT YET RECRUITING

CHU Tours - Hôpital Bretonneau

Tours, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

RECRUITING

Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Renaud De Crevoisier, PR

  Centre Eugène Marquis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Gestin, PhD

CONTACT

+33(0)299253036; m.gestin@rennes.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 5, 2019
• Study Start: October 4, 2019
• Primary Completion (Estimated): April 4, 2030
• Study Completion (Estimated): April 4, 2031
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)